Update on the Activities of The NELAC Institute (TNI)

1. Update on the Activities of The NELAC Institute(TNI) September 21, 2011

2. 2010 Accomplishments • Major reorganization • 20 regional workshops on new laboratory standards • Draft Quality Management Plan • Strategic Plan for 2010 – 2015 • Awarded funding for two cooperative agreements from EPA competitions for years 2010 – 2015 • Field Sampling and Measurement Organizations accreditation program created (NEFAP) • Several new groups formed to tackle specific issues • New Quality Manual Template developed • New Expert Committee to tackle method issues (EMMEC)

3. EMMEC

4. Consensus Standards Development • Expert committees develop standards consistent with TNI’s mission, using a consensus process • Expert Committees • Accreditation Body • Field Activities • On-Site Assessment • Proficiency Testing • Quality Systems • Stationary Source Audit Sample • Environmental Measurement Methods

5. Expert Committee Activities • Proficiency Testing Committee • Numerous Tentative Interim Amendments (TIAs) and Standards Interpretation requests (SIRs) • Requests for changes to the standard in order to implement • Working Draft Standard (WDS) under development • On-Site Assessment Committee • Development of guidance document • Assessment of training in technical disciplines • Considering merger with AB Committee

6. Quality Systems Committee Numerous SIRs WDS posted for comment Voting Draft Standard next Assessment checklist http://www.nelac-institute.org/qscheck2009-access.php Accreditation Body Committee Completed “Provisional Recognition” SOP for ABs not able to satisfy non-conformances Considering merger with OSA Committee Expert Committee Activities (cont.)

7. Expert Committee Activities (cont.) • Field Activities Committee • SIRs • FSMO V1 and V2 scheduled to be revised • Subcommittees on Stack Sampling being formed • Collection Media Subcommittee formed • Focus of activity on development of NEFAP

8. Expert Committee Activities (cont.) • Stationary Source Audit Sample Committee • New EPA regulations in-place • TIAs developed and resolved for consistency with new EPA regulation • EPA approved the SSAS program on May 17 • Updated SSAS tables • Environmental Measurement Methods Committee • Working on a background guidance document for calibration • Outline of consensus standard on calibration developed

9. Environmental Measurement Methods Expert Committee • Chartered to work on • Limits of Detection (LOD) • Limits of Quantitation (LOQ), • Instrument calibration • other fundamental concepts • Goal is to have new consensus standards developed by 2012 • Funding support provided by cooperative agreement with EPA • First meeting was January 7, 2011

10. Standards InterpretationsNELAP and NEFAP • On-line request form • www.nelac-institute.org/interpret-request.php • Requests are catalogued, reviewed and directed to the appropriate body for consensus resolution • Preliminary opinion developed • Opinion endorsed by NELAP AC or NEFAP EC • Interpretation posted on website

11. Interpretation Process • NOT to be used to escalate a dispute between a laboratory or an FSMO and an AB • Some requests relate to method or EPA program interpretations • Laboratories should attempt to reconcile all such interpretations with the applicable method publisher or EPA Program

12. NELAP Accomplishments • Implemented a new process for AB evaluations • Developed SOP for general complaint resolution and reaffirmed existing procedures • Increased number of Accreditation Bodies to 15 • Establish web application for endorsing SIRs • Developed comprehensive plan for implementation of new TNI Standards

13. NELAP Accreditation Bodies NELAP Accreditation Body Working on Application Accept NELAP Incorporate NELAP elements

14. NELAP Plans • Implement the 2009 TNI standard • Continue renewal evaluations for ABs • 9 are under way • Implement national database of accredited laboratories (LAMS) • Finalize handbook for small laboratories (TAC)

15. NEFAP • Consensus standards that are voluntarily adopted by state agencies or third partiesapproved as Accreditation Bodies (ABs) • NEFAP Executive Committee oversees ABs to assure uniformity • AB grants accreditation, which is unconditionally recognized by other participating ABs • Program applies to Field Sampling and Measurement Organizations (FSMOs)

16. Field Sampling and Measurement Organization (FSMO) Organization engaged in: • environmental sampling for laboratory analysis and/or • field measurement outside of an enclosed structure that meets the requirements of fixed or mobile laboratory

17. NEFAP Activities Accomplishments Future Plans Recognize ABs (4 so far) A2LA ACLASS L-A-B PJLAB Conduct training and outreach ABs accept applications from FSMOs • Began efforts in two key areas: • Lead-based paint • Stack testing • Revised TNI Bylaws to accommodate NEFAP • Built AB recognition process • Developed Policies & Procedures

18. PT Program Accomplishments • Two PT Provider Accreditor (PTPA) evaluations completed in 2010 • New applicant, ACLASS • Re-evaluation of A2LA • Improved and clarified the PTPA evaluation SOP • Completed updates to all PT Program SOPs • Formed a Field PT Subcommittee • FoPT table for Lead in soil, paint films, and dust wipes effective January 3, 2012 • Formed a Protozoa PT Subcommittee • Reviewed and approved an update to the Drinking Water FoPT table • Retired the Experimental FoPT tables

19. Chemistry FoPT • Reviewing each analyte on the Non-Potable Water FoPT table • Review to be completed this summer • Subcommittee will review and update each analyte on the Solid & Chemical Materials FoPT table

20. WET FoPT • Identifying which endpoints make sense and if there are some that do not make sense • Temperature variation has been eliminated to increase WET study sizes • Discussing the possibility of eliminating the hypothetical estimates (such as NOEC) and substitute an endpoint test (such as IC25) • Review of the FoPT table to be completed within a year

21. PT Program Plans • Implement updates to the Drinking Water, Non-potable Water, and Solid & Chemical Materials FoPT tables • Implement a Field FoPT table (Lead in paint) • Implement a Protozoa FoPT table (Cryptosporidium) • Define and implement a process for addition and removal of analytes from FoPT tables

22. PT Program Summary • There are now two TNI-recognized PT Provider Accreditors – A2LA and ACLASS • Two new FoPT tables are planned for implementation in 2011 • Field (Lead in Paint) • Protozoa (Cryptosporidium) • Be on the watch for updates to FoPT • Drinking Water • Non-Potable Water • Solid & Chemical Materials • WET

23. Administration and Support • Board of Directors • Advocacy • Finance • Information Technology • Nominating • Policy • Conference Planning

24. TNI Board of Directors • Monitor activities of all programs and committees • Organizational and fiduciary leadership • Form ad-hoc groups for special topics • Consistency Improvement Task Force • Accreditation Body Task Force

25. Ad-hoc Groups • Consistency Improvement Task Force • Establishing Realistic Expectations about Consistency • On-Site Assessments of Laboratories • Evaluations of Accreditation Bodies • Laboratories and Users of Laboratory Services • Accreditation Body Task Force • TNI support to NELAP ABs • Final Report to the Board on July 13 • 8 options recommended with priorities, time frames and leads for implementation

26. ABTF Findings and Recommended Options

27. 1. Training • Develop web-based technical training for assessors in 2011 • Develop web-based training on how manage an accreditation program • Develop more extensive web-based training on Volume 2 • Explore a partnership with EPA for use of DW officer certification training Lead: Technical Assistance Committee

28. 2. Administrative Support Services • Develop a generic TNI application & central database for laboratory applications • Develop and maintain a list of which AB can offer a primary accreditation to laboratories not located within their state • Develop tracking tools to assist ABs with tracking • PT data • Corrective actions Lead: Accreditation Body Committee

29. 3. National Database • Continue the implementation of the database as a high priority for 2011 • All laboratory demographic data are now in database • Fields of Accreditation data being entered • Preview database at www.nelac-institute.org/lams Lead: Information Technology Committee

30. 4. Use of Third Party Assessors • Develop a process for TNI to qualify third-party assessors • Develop a model solicitation template for states to use in contracting • Develop a process for performance review of third-party assessors that TNI qualifies. • Develop a service for a state to contract with TNI to obtain the use of third-party assessors Lead: Accreditation Body Committee

31. 5. Use of Assessments Performed by Other Accreditation Bodies • Explore the feasibility of partnering with DoE and the DoD-approved ABs to use their assessment reports Lead: NELAP Accreditation Council

32. 6. Sharing of Information and Resources • Explore sharing assessors or assessment reports between states • Develop a process for sharing example form letters for AB assessments and related activities • Use TNI’s Assessment Forum and Mentor Sessions to share best practices among ABs. • Establish a Discussion Board comparable to the Discussion Board for the Small Laboratory Advocacy Group Lead: Accreditation Body Committee

33. 7. Surveillance Assessments • Form a task force to investigate how surveillance assessments could be implemented in a formal and objective process with consistent criteria • Develop a model on how surveillance assessments could be used to extend the frequency of a full reassessment for more than two years • Use the results from this effort to develop a recommendation on changing Volume 2 Lead: Laboratory Accreditation System Committee

34. 8. Non-Governmental Accreditation Bodies • Ensure any non-governmental ABs have the ability to operate a NELAP accreditation program according to TNI expectations, including: • Participating in AB evaluations, • Payment of appropriate fees, and • Adhering to the requirements in Volume 2 of the TNI Standard Lead: AB Task Force

35. Non-Governmental Accreditation Bodies • Determine if the TNI Standard (Volume 2) and Bylaws need to be clarified or revised to allow for non-governmental ABs • Determine if any changes are needed to the existing recognition process in order to recognize non-governmental ABs • Make sure this process does not duplicate efforts in the NEFAP recognition process for those organizations that offer accreditations in both programs

36. Non-Governmental Accreditation Bodies • Develop a process by which a state agency can recognize a non-governmental AB to accredit labs in their state • A non-governmental AB could include an AB closely affiliated with TNI • Explore the feasibility of a process that would allow a NELAP AB to accept the accreditation of a laboratory that is accredited by another state-recognized non-governmental AB

37. AB Recommendations • Significant progress expected to occur by January 2012 • Effort will be a major focus of TNI January meeting • Opportunities for volunteers to work on these efforts • Participate in TNI committees • Participate on AB Task Force

38. Advocacy Activities Recent Accomplishments Future Plans Continue outreach to stakeholders Continue publication of newsletters Develop new brochures Meet with EPA program offices Work with APHL • Presentations at >10 regional and national meetings • Published newsletters • Met with EPA RS&T Directors • Exhibited at ASDWA meeting • Developed new logos and banners

39. Small Laboratory Advocacy Group (SLAG) • Open to TNI members and non-members • http://www.nelac-institute.org/board/ • Keith Chapman, City of Salem • kchapman@cityofsalem.net • Seeks input from small laboratories and provides advice to TNI • Raises concerns of small laboratories to high visibility in TNI

40. Future Meetings Winter Meeting Summer Meeting Washington, DC August 2012 • Sarasota, FL • January 2012

41. TNI Cooperative Agreements with EPA Former (2006 – 2010) New (2010 – 2015) $750,000 to develop measurement tools, accreditation standards and technical support $500,000 to manage the National Environmental Monitoring Conference • $400,000 for Standards Development and Technical Assistance • $300,000 to manage the National Environmental Monitoring Conference

42. Measurement Tools • Establish the Environmental Measurement Methods Expert Committee (EMMEC) • Implement a comprehensive educational delivery system • Provide assessor training, support outreach to organizations that are not accredited and refine TNI’s consensus standards • Establish a robust and effective on-line Methods Compendium

43. Educational Delivery System • New EDS/training pages on TNI website • Educational opportunities • Application to provide training • Needs survey • Training developed by TNI and others • “Live” training courses • Webinars • Webcasts

44. New Quality Manual Template • Now available • Organized according to V1, M2 • Price is $95 for TNI members • $250 for non-members • Will include free access to Webinar/Webcast for training • $50 credit for those that purchased the old template

45. 2012 and Beyond Implement the adopted NELAP standards Implement the FSMO accreditation program Implement a Stationary Source Audit Sample Program Develop and refine a comprehensive training program Implement a national database of accredited laboratories Continue to develop consensus standards that meet the needs of the community

46. Summary • TNI has had a terrific 2011 and is planning continued growth for 2012 • We invite you to actively participate in our activities • Join TNI – Now over 850 active members! • Join a TNI committee – Nothing happens without our volunteers!

47. Contact TNI Jerry Parr, Executive Director • www.nelac-institute.org • jerry.parr@nelac-institute.org • 817-598-1624